Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT02171234
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02171234
Study Brief: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo PLC, Placebo None None 0 8 4 8 View
Group 1 - BIA 2-093 200 mg b.i.d. BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily) None None 0 6 4 6 View
Group 2 - BIA 2-093 400 mg o.d. BIA 2-093, ESL, Eslicarbazepine acetate 400mg None None 0 6 4 6 View
Group 3 - BIA 2-093 800 mg o.d. BIA 2-093, ESL, Eslicarbazepine acetate 800mg None None 0 6 3 6 View
Group 4 - BIA 2-093 1200 mg o.d. BIA 2-093, ESL, Eslicarbazepine acetate 1200mg None None 0 6 4 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flushing None Nervous system disorders None View
Mouth dry None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Muscle contractions involuntary None Nervous system disorders None View
Dyspepsia None Gastrointestinal disorders None View
Gingival bleeding None Gastrointestinal disorders None View
Mucositis NOS None Gastrointestinal disorders None View
Hepatic enzymes increased None Hepatobiliary disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Skeletal pain None Musculoskeletal and connective tissue disorders None View
Concentration impaired None Psychiatric disorders None View
Dreaming abnormal None Psychiatric disorders None View
Hallucination None Psychiatric disorders None View
Somnolence None Psychiatric disorders None View
Nausea None Gastrointestinal disorders None View
Herpes simplex None Immune system disorders None View
Pharyngitis None Respiratory, thoracic and mediastinal disorders None View
Upper resp tract infection None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Skin dry None Skin and subcutaneous tissue disorders None View
Conjunctivitis None Eye disorders None View